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The Evolving Pharma Landscape: Innovation Demands AgilityThe pharmaceutical industry is a dynamic ecosystem where innovation never sleeps. From advancements in manufacturing technologies to shifts in formulation strategies, post-approval changes are inevitable. Yet, every modification—whether to processes, equipment, or product composition—carries […]
Introduction The landscape of clinical trials is undergoing a seismic shift. No longer confined to rigid protocols and centralized labs, modern clinical research is embracing patient-centric innovation to deliver faster, safer, and more inclusive outcomes. By prioritizing patient empowerment and […]
EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation (EU MDR) and the United […]
Several Emerging trends are shaping the Pharmacovigilance and Regulatory Affairs domains in 2025 making their collaboration even more critical: 1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) AI and ML are revolutionizing both PV and RA processes. AI-driven […]
IntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This approval is a beacon of […]
EU GPSR (General Product Safety Regulation) The EU GPSR General Product Safety Regulation is a regulatory framework in the European Union that aims to ensure that products placed on the market are safe for consumers. It applies to all products […]
Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions process.
Hyderabad, the capital of Telangana, has emerged as a prominent pharma hub in India, attracting global pharmaceutical companies and investors. Its strategic location, coupled with a favourable business environment, has made it a preferred destination for pharmaceutical manufacturing, research, and […]
The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing drug safety, efficacy, and accessibility. […]
At Vigilare Biopharma We strongly believe that medications play a crucial role in modern healthcare, but their benefits are intricately linked to their safety. A robust pharmacovigilance system is vital to ensure that medications are used safely and effectively. This […]
